CAR T-cells, innovative fusion proteins engineered to target cancer cells, have become a standard therapy for relapsed or refractory B-cell lymphomas, B-cell acute lymphoblastic leukemia, and multiple myeloma; however, the US FDA is probing potential links between CAR T-cell immunotherapies and secondary blood cancers, prompted by reports of T-cell malignancies, including CAR-positive lymphoma, among patients treated with BCMA-directed or CD19-directed autologous CAR T-cell immunotherapies, emphasizing the need for continued evaluation of risks versus benefits and potential regulatory action. The FDA has received 20 reports of T-cell malignancies following immunotherapy.1

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References

  1. Nelson, R. (2023). FDA investigating safety risks in CAR T-cell recipients. The Lancet, 402(10418), 2181. https://doi.org/10.1016/s0140-6736(23)02747-2

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